Control of Emissions From Manufacture of Synthesized Pharmaceutical Products

PURPOSE: This rule restricts volatile organic compound emissions from the manufacture of synthesized pharmaceutical products. (1) Application. (A) This rule shall apply throughout St. Louis City and Jefferson, St. Charles, Franklin and St. Louis Counties. (B) This rule applies to all synthesized pharmaceutical manufacturing installations. (C) This rule applies only to operations including reactors, distillation units, dryers, storage of volatile organic compounds (VOCs), transfer of VOC, extraction equipment, filters, crystallizers and centrifuges that individually and uncontrolled would emit fifteen pounds (15 lbs.) per day or more of VOC. (D) This rule does not apply to operations used exclusively for chemical or physical analysis or determination of product quality and commercial acceptance (such as research facilities, pilot plant operations and laboratories) unless— 1. The operation is an integral part of the production process; or 2. The emissions from the operation exceed three hundred sixty-three kilograms (363 kg) (eight hundred 800 lbs.) in any calendar month. (2) Definitions of certain terms specified in this rule may be found in 10 CSR 10-6.020. (3) Operating Equipment and Operating Procedure Requirements. (A) The owner or operator of a synthesized pharmaceutical manufacturing facility subject to this rule shall control the VOC emissions from all reactors, distillation operations, crystallizers, centrifuges and vacuum dryers by the use of surface condensers or equivalent controls. 1. If surface condensers are used, with vapor pressures as measured at twenty degrees Celsius (20 °C), the condenser outlet gas temperature must not exceed— A. Minus twenty-five degrees Celsius (-25 °C), when condensing VOC of vapor pressure greater than 40.0 kilopascals (kPa) (5.8 psi); B. Minus fifteen degrees Celsius (-15 °C), when condensing VOC of vapor pressure greater than 20.0 kPa (2.9 psi); C. Zero degrees Celsius (0 °C), when condensing VOC of vapor pressure greater than 10.0 kPa (1.5 psi); D. Ten degrees Celsius (10 °C), when condensing VOC of vapor pressure greater than 7.0 kPa (1.0 psi); or E. Twenty-five degrees Celsius (25 °C), when condensing VOC of vapor pressure greater than 3.50 kPa (0.5 psi). 2. If equivalent controls are used, the VOC emissions must be reduced by an amount equivalent to the reductions achieved in paragraph (3)(A)1. Equivalent controls may not be used unless approved by the director. (B) The owner or operator of a synthesized pharmaceutical manufacturing installation subject to this rule shall reduce the VOC emissions from all air dryers and production equipment exhaust systems— 1. By at least ninety percent (90%) if emissions are one hundred fifty (150) kg/day, Specific to the St. Louis Metropolitan Area three hundred thirty (330) lbs./day or more of VOC; or 2. To fifteen (15) kg/day thirty-three (33) lbs./day or less if emissions are less than one hundred fifty (150) kg/day, three hundred thirty (330) lbs./day of VOC. (C) The owner or operator of a synthesized pharmaceutical manufacturing installation subject to this rule shall— 1. Provide a vapor recovery system or equivalent control that is ninety percent (90%) or more effective in reducing daily average emissions from truck or railcar deliveries to storage tanks with capacities greater than seven thousand five hundred (7,500) liters (two thousand (2,000) gallons) that store VOC with vapor pressures greater than 28.0 kPa (4.1 psi) at twenty degrees Celsius (20 °C); and 2. Install pressure/vacuum conservation vents set at ±0.2 kPa on all storage tanks that store VOC with vapor pressures greater than 10.0 kPa (1.5 psi) at twenty degrees Celsius (20 °C), unless a more effective control system is used. (D) The owner or operator of a synthesized pharmaceutical manufacturing installation subject to this rule shall enclose all centrifuges, rotary vacuum filters and other filters having an exposed liquid surface, where the liquid contains VOC and exerts a total VOC vapor pressure of 3.50 kPa (0.5 psi) or more at twenty degrees Celsius (20 °C). (E) The owner or operator of a synthesized pharmaceutical manufacturing installation subject to this rule shall install covers on all in-process tanks containing a VOC at any time. These covers must remain closed, unless production, sampling, maintenance or inspection procedures require operator access. (F) The owner or operator of a synthesized pharmaceutical manufacturing installation subject to this rule shall repair all leaks from which a liquid containing VOC can be observed running or dripping. The repair shall be completed the first time the equipment is off-line for a period of time long enough to complete the repair. (4) Compliance Determination and Record Keeping. (A) Compliance with this rule in subsections (3)(A) and (B) and paragraph (3)(C)1. shall be determined by the testing methods referenced in 10 CSR 10-6.030(14)(A). (B) Owners or operators utilizing add-on control technology shall monitor and record the following parameters continuously while the affected equipment is in operation: 1. Exhaust gas temperature of all incinerators; 2. Temperature rise across a catalytic incinerator bed; 3. VOC breakthrough on a carbon adsorption unit; 4. Exit stream temperature on all condensers; and 5. Any other monitoring device requested by the director. (C) Records shall be kept on production rates sufficient to determine daily VOC emissions and any equipment test results performed in conjunction with this rule. (D) Records of all information requested in subsection (4)(B) shall be kept for a period of not less than two (2) years and all these records shall be made available to the director upon his/her request. (5) Compliance Dates. (A) The owner or operator of a synthesized pharmaceutical manufacturing installation subject to this rule must submit a final control plan to the director by December 31, 1980, for his/her approval. This plan must include the following: 1. A detailed plan of process modifications; and 2. A time schedule for compliance containing increments of progress and a final compliance date. (B) Compliance with this rule shall be accomplished by any installation as expeditiously as practicable, but in no case shall final compliance extend beyond December 31, 1982. AUTHORITY: section 643.050, RSMo 1994.* Original rule filed March 13, 1980, effective Sept. 12, 1980. Amended: Filed Oct. 4, 1988, effective March 11, 1989. *Original authority: 643.050, RSMo 1965, amended 1972, 1992, 1993.